Palivizumab Injection

(pal i vi' zu mab)

Brand Name(s):

Synagis®

WHY is this medicine prescribed?

Your child's doctor has ordered palivizumab to help prevent a serious lower respiratory tract disease called respiratory syncytial virus (RSV). The drug will be injected into a large muscle (such as the thigh) once a month for several months.

It is important that your child receive this medicine each month during RSV season. Your health care provider will let you know when the monthly injections are no longer needed.

Your child's health care provider (doctor, nurse, or pharmacist) may measure the effectiveness and side effects of this treatment using laboratory tests and physical examinations. It is important to keep all appointments with your child's doctor and the laboratory. The length of treatment will be determined by your child's health care provider.

What SPECIAL PRECAUTIONS should I follow?

Before administering palivizumab,

tell your child's doctor and pharmacist if your child is allergic to palivizumab or has had a reaction to palivizumab or any other drugs.

tell your doctor and pharmacist what prescription and nonprescription medications your child is taking, including vitamins.

tell your child's doctor if your child has or has ever had bleeding problems or a low platelet count.

HOW should this medicine be used?

Before you administer palivizumab to your child, you will need to mix it up. Your health care provider should show you how to mix and measure the first dose. You will need to use a needle and syringe to draw up 1 mL of sterile water into the syringe. Slowly add the sterile water to the palivizumab vial. Gently swirl the vial (do not shake it) for 30 seconds. You will then need to let the vial sit at room temperature for 20 minutes until the solution becomes clear. After 20 minutes, you are ready to give your child palivizumab. The solution should be clear and free of floating material. Do not use the solution if it is discolored or if it contains particles. Call your health care provider if you are unsure whether you should use the solution.

It is important to use this medicine exactly as directed. Do not stop giving this medicine to your child without talking to your child's health care provider. Do not change the dosing schedule without talking to your child's health care provider.

What SIDE EFFECTS can this medicine cause?

Palivizumab may cause side effects. Tell your child's health care provider if any of these symptoms are severe or do not go away:

sore throat

runny nose

redness or irritation at injection site

vomiting

diarrhea

If your child experiences any of the following symptoms, call your child's health care provider immediately:

severe skin rash

itching

hives

difficulty breathing

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at Web Site] or by phone [1-800-332-1088].

What should I know about STORAGE and DISPOSAL of this medication?

Your child's health care provider will probably give you a 1-month supply of palivizumab at a time. You will need to store it in the refrigerator.

Do not allow palivizumab to freeze.

Palivizumab must be used within 6 hours once you mix it. Your health care provider will give you directions on how to prepare each dose.

Store this medication only as directed. Make sure you understand what you need to store this medication properly.Keep your supplies in a clean, dry place when you are not using them, and keep all medications and supplies out of the reach of children. Your health care provider will tell you how to throw away used needles, syringes, and containers to avoid accidental injury.

What should I do in case of OVERDOSE?

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

If you are receiving palivizumab under your skin, you need to know the symptoms of a catheter-related infection (an infection where the needle enters your skin). If you notice any of the following symptoms, tell your health care provider as soon as possible:

Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.